Trial Outcomes & Findings for An Innovative Taping Technique for Improved Intravenous (IV) Catheter Securement (NCT NCT05948878)

NCT ID: NCT05948878

Last Updated: 2026-04-15

Results Overview

We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Until the tape is dislodged- approximately 15 seconds

Results posted on

2026-04-15

Participant Flow

Participant milestones

Participant milestones
Measure
Retrograde Directional Test
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
90 Degrees Directional Test
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
Overall Study
STARTED
16
16
Overall Study
COMPLETED
14
16
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Retrograde Directional Test
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
90 Degrees Directional Test
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized.
Overall Study
Equipment failure
2
0

Baseline Characteristics

Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Retrograde Directional Test
n=14 Participants
Subjects during the Retrograde Directional Test will have the three taping methods placed on their left and/or right antecubital fossa region to superficially secure an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the Retrograde Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
90 Degrees Directional Test
n=16 Participants
Subjects during the 90 Degrees Directional Test will have the three taping methods placed on their left and right antecubital fossa region, superficially taping an IV catheter (i.e., the catheter will be placed on top of the participant's skin and not in the vein but will be taped as if the catheter was placed intravenously). Six total measurements will be obtained of which three will be using the 90 Degrees Directional Test (i.e., each taping method will undergo testing for each directional method). The order of placing the different taping methods and the direction testing will be randomized. Novel Taping Method: Subjects will be asked to have the novel taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. BCH Emergency Department Taping Method: Subjects will be asked to have the BCH emergency department taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter. Chevron Taping Method: Subjects will be asked to have the Chevron taping method placed on their left and right antecubital fossa region, superficially taping an IV catheter.
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
0 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
0 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Age, Categorical
Between 18 and 65 years
14 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
16 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
30 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Age, Categorical
>=65 years
0 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
0 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
0 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Sex: Female, Male
Female
12 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
8 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
20 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Sex: Female, Male
Male
2 Participants
n=14 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
8 Participants
n=16 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
10 Participants
n=30 Participants • Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
14 Participants
n=14 Participants • 2 participants were withdrawn due to equipment error.
16 Participants
n=16 Participants • 2 participants were withdrawn due to equipment error.
30 Participants
n=30 Participants • 2 participants were withdrawn due to equipment error.
Acceptable Skin State
14 Participants
n=14 Participants
16 Participants
n=16 Participants
30 Participants
n=30 Participants

PRIMARY outcome

Timeframe: Until the tape is dislodged- approximately 15 seconds

We will examine the maximum force the taping methods can withstand as measured by the force gauge in the retrograde direction, distally from the insertion site.

Outcome measures

Outcome measures
Measure
Novel Taping
n=30 Participants
The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
Chevron Taping
n=30 Participants
The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
ED Taping
n=30 Participants
The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
The Force (Newtons) Required to Dislodge an IV Catheter Secured in the Retrograde Direction.
28.65 Newtons
Standard Deviation 8.15
15.41 Newtons
Standard Deviation 4.22
19.29 Newtons
Standard Deviation 6.81

PRIMARY outcome

Timeframe: Until the tape is dislodged- approximately 15 seconds

Population: Numbers represent number of participants randomized to start with retrograde directional test or 90 degrees directional test. All participants cross-overed and therefore, were subjected to both tests regardless of randomization.

We will examine the maximum force the taping methods can withstand as measured by the force gauge in a 90 degrees direction, medially from the insertion site.

Outcome measures

Outcome measures
Measure
Novel Taping
n=30 Participants
The novel taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
Chevron Taping
n=30 Participants
The Chevron taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
ED Taping
n=30 Participants
The ED taping method will be employed to measure the maximum force (Newtons) required to dislodge an IV catheter (without puncturing of skin) secured in the retrograde direction, distally from the insertion site.
The Force (Newtons) Required to Dislodge an IV Catheter Secured in a 90 Degrees Direction.
20.85 Newtons
Standard Deviation 6.51
13.68 Newtons
Standard Deviation 4.02
13.16 Newtons
Standard Deviation 4.55

Adverse Events

Retrograde Directional Test: Novel Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Retrograde Directional Test: Chevron Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Retrograde Directional Test: ED Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

90 Degrees Directional Test: Novel Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

90 Degrees Directional Test: Chevron Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

90 Degrees Directional Test: ED Taping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pete Kovatsis

Boston Children's Hospital

Phone: 617-355-6225

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place